UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005004 |
|---|---|
| Receipt number | R000005942 |
| Scientific Title | Spiritual care of cancer patients by integrated medicine in a forest park |
| Date of disclosure of the study information | 2011/02/02 |
| Last modified on | 2011/02/02 14:44:04 |
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Basic information
Public title
Spiritual care of cancer patients by integrated medicine in a forest park
Acronym
Spiritual care of cancer patients in a forest park
Scientific Title
Spiritual care of cancer patients by integrated medicine in a forest park
Scientific Title:Acronym
Spiritual care of cancer patients in a forest park
Region
| Japan |
Condition
Condition
breast cancer, lung cancer
Classification by specialty
| Chest surgery | Breast surgery | Psychiatry |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Psycho-oncological care including spiritual care is essential for cancer patients. Integrated medicine, a therapy combining modern western medicine with various kinds of complementary and alternative medicine (CAM), can be appropriate for the spiritual care of cancer because of the multidimensional characteristics of the spirituality. In particular, therapies that enable patients to establish a deeper contact with nature, inspire feelings of life and growth of plants, and involve meditation may be useful for spiritual care. The purpose of our study was to examine the effect of spiritual care of cancer patients by integrated medicine in a green environment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Spirituality (the Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing; FACIT-Sp) before and after intervention
Key secondary outcomes
Quality of life (QOL; SF-36), fatigue (cancer fatigue scale; CFS), psychological state (POMS and STAI), circadian rhythm and NK cell activity before and after intervention
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
A program consisted of forest therapy, horticultural therapy, yoga meditation and support group therapy once a week for 12 weeks
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients who had been diagnosed with cancer.
2. Patients aged between 20 and 70 years.
3. More than 1 month had passed after the patient had undergone surgery, chemotherapy or irradiation.
4. Patients judged by a physician to be able to participate in the study.
5. Selection was made irrespective of type and progression of cancer.
Key exclusion criteria
Patients who do not meet inclusion criteria
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jiro Imanishi |
Organization
Kyoto Prefectural University of Meidicine Graduate School of Medical Science
Division name
Department of Microbiology
Zip code
Address
465, Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5330
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jiro Imanishi |
Organization
Meiji University of Integrative Medicine
Division name
Center for Integrative Meidicine
Zip code
Address
2-4, Higashisakaidani-cho, Ooharano, Nishikyo-ku, Kyoto, Japan
TEL
075-333-1386
Homepage URL
imanishi-micro@nifty.com
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Commemorative Organization for the Japan World Exposition' 70
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kyoto University, Osaka University, and Takatsuki Red Cross Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
万博公園（大阪府）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2007 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 02 | Day |
Last modified on
| 2011 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005942
